Bone graft delivery system and method for using same

ABSTRACT

A bone graft delivery system can include an elongate tube and a handle having a trigger and a ratcheting mechanism. The trigger is actuated to deliver bone graft material through the tube. The bone graft delivery system can further include a distal tip at a distal end of the tube. The tip has one or more openings to deliver the bone graft material to a desired location and includes a surface suitable to act as a rasp for decorticating bone. A method for delivering bone graft material to a desired surgical location includes providing a bone graft delivery device, positioning the device adjacent the surgical location, decorticating bone, and delivering bone graft material to the surgical location.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57. Thepresent application claims the priority benefit of U.S. ProvisionalApplication No. 62/102,471, filed Jan. 12, 2015, the entirety of whichis hereby incorporated by reference herein.

BACKGROUND Field

The present application relates to orthopedic surgery in general, andmore particularly, to bone graft delivery systems and methods.

Description of the Related Art

In a bone grafting procedure, a surgeon places bone or a bone substituteinto an area in a patient's body to provide a type of scaffold for bonegrowth and repair. Bone grafts can be used to help treat variousorthopedic problems, for example, to fuse a joint or repair a fracture.Bone graft material can be, for example, autogenous (harvested from thepatient's own body), allogeneic (harvested from another person, usuallya cadaver), or synthetic. Many bone grafting procedures are performedvia open surgery implantation. However, these procedures can also beperformed minimally invasively, for example, by using a needle to injectthe bone graft material into the target location without requiring asurgical incision.

In some cases decortication of the bony area receiving the graft isperformed prior to delivery of the bone graft material. Decorticationremoves superficial cortical bone and exposes the underlying cancellousbone, which can help accelerate the integration of the bone graft withthe native bone.

SUMMARY

The devices, systems, and methods described herein allow for minimallyinvasive delivery of bone graft material to a desired location in apatient's body. In some embodiments, the devices, systems, and methodsdescribed herein allow for delivery of bone graft material to a desiredlocation in an open or mini-open procedure. In some embodiments, thedevices, systems, and methods described herein also provide for bonedecortication.

In some embodiments, a bone graft delivery system includes an elongatedtube, a handle at a proximal end of the tube, and a tip at a distal endof the tube. The handle is configured to be actuated to deliver bonegraft material through the tube. The tip includes one or more openingsconfigured to deliver the bone graft material to a desired location anda surface suitable to serve as a rasp for scraping bone.

In some embodiments, the rasping surface of the tip includes jaggededges. The tip can be made of a metal, a radiopaque material, a durablemedical plastic, a composite material, or another material orcombination of materials. In some embodiments, the tip includes one ormore radiopaque markers. The tip can have a sharp or blunt end. The tipcan be removably attachable to the distal end of the tube.Alternatively, the tip can be integrally formed or permanently coupledto the distal end of the tube. In some embodiments the tube is rigid. Inother embodiments the tube is at least somewhat bendable. In someembodiments the tube is straight, while in other embodiments the tubeincludes a permanent bend. The handle can include a trigger configuredto be actuated to deliver the bone graft material through the tube. Insome embodiments, the bone graft delivery system includes an endoscopiccamera positioned adjacent the tip.

In some embodiments, a method for delivering bone graft material to asurgical location includes providing a bone graft delivery device andpositioning the device adjacent the surgical location. The bone graftdelivery device comprises an elongate tube and a distal tip. The distaltip includes at least one opening for delivering the bone graft materialto the surgical location. The method further includes decorticating bonewith the distal tip and delivering bone graft material through the tubeand out the at least one opening of the tip.

The bone graft material can be one or more autogenous, allogenic,cadaveric, and/or synthetic materials. In some embodiments, the bonegraft delivery device is positioned at the surgical location through aminimally invasive opening in a patient's skin. In some embodiments, thesurgical location is a portion of the patient's spine, so the bone graftdelivery device is positioned adjacent to the spine and the distal tipdecorticates a portion of the spine. In some embodiments, decorticatingbone with the distal tip is accomplished by rasping bone with jaggededges of the distal tip. In some embodiments, bone is decorticated withthe distal tip by actuating the distal tip with mechanical, batterypowered, electric, pneumatic, or other means of force.

In some embodiments, a bone graft delivery system includes an elongatetube and a handle at a proximal end of the tube configured to beactuated to deliver bone graft material through the tube. The tube canbe removably coupled to the handle. In some embodiments, a distal end ofthe tube can be configured to couple to an interbody device disposedwithin a disc space to deliver bone graft within the interbody device.In some embodiments, the handle includes a trigger configured to beactuated to deliver bone graft material through the tube. In someembodiments, the handle includes a funnel configured to receive bonegraft material, a channel in fluid communication with the funnel and theproximal end of the tube, and a ratcheting mechanism configured toadvance bone graft material distally through the tube. The bone graftdelivery system can further include a plunger configured to be removablyreceived in the channel and tube.

The channel can include a window along at least one side of the channel,and the handle can further include a sheath movably disposed within thechannel and configured to selectively cover the window of the channel.The ratcheting mechanism can include a pawl operatively coupled to thetrigger, the plunger can include a series of notches, and the pawl canbe configured to engage the notches of the plunger through the window ofthe channel when the plunger is inserted into the channel and the windowis at least partially uncovered.

In some embodiments, a bone graft delivery system kit includes a handle,one or more elongate tubes configured to be coupled to the handle, andone or more plungers configured to be removably received in the handleand tube. The kit can further include one or more tips configured to becoupled to a distal end of the tube and having one or more openingsconfigured to deliver bone graft material to a desired location and asurface configured to decorticate bone.

In some embodiments, a method for delivering bone graft material to asurgical location includes providing a bone graft delivery device. Thebone graft delivery device can include an elongate tube and a handle ata proximal end of the tube that includes a ratcheting mechanism, atrigger operatively coupled to the ratcheting mechanism, a proximalopening, and a lumen extending between and in fluid communication withthe proximal opening and proximal end of the tube. The method furtherincludes loading bone graft material into the bone graft deliverydevice, for example into the proximal opening, inserting a plunger intothe lumen and tube, and manipulating the trigger so that the ratchetingmechanism engages the plunger. In some embodiments, the method furtherincludes coupling a distal end of the elongate tube to an interbodyimplant positioned within a disc space and delivering bone graftmaterial within the interbody implant.

In some embodiments, an interbody implant includes a leading end, atrailing end, first and second sidewalls extending between the leadingend and the trailing end, and a central opening bounded by the leadingend, trailing end, and first and second sidewalls. The trailing endincludes a hole in fluid communication with the central opening, and aperimeter of the hole includes engagement features configured to matewith corresponding engagement features on a distal end of a tube of abone graft delivery device. At least one of the first and secondsidewalls can include at least one hold in fluid communication with thecentral opening. A perimeter of the at least one hole can be taperedoutwardly from an inner surface to an outer surface of the at least oneof the first and second sidewalls.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a side view of an example embodiment of a bone graftdelivery device;

FIG. 1B illustrates a perspective view of the bone graft delivery deviceof FIG. 1A;

FIGS. 2A and 2B illustrate perspective views of another exampleembodiment of a bone graft delivery device;

FIG. 2C illustrates a side view of another example embodiment of a bonegraft delivery device;

FIG. 2D illustrates a section view of the bone graft delivery device ofFIG. 2C;

FIG. 2E illustrates a section view of the bone graft delivery device ofFIGS. 2C and 2D including a pusher rod;

FIG. 2F illustrates a side view of another example embodiment of a bonegraft delivery device;

FIG. 2G illustrates a section view of the bone graft delivery device ofFIG. 2F;

FIG. 2H illustrates a section view of the bone graft delivery device ofFIGS. 2F and 2G including a pusher rod;

FIG. 2I illustrates a bottom view of another example embodiment of abone graft delivery device;

FIG. 2J illustrates a section view of the bone graft delivery device ofFIG. 2I;

FIG. 2K illustrates a section view of the bone graft delivery device ofFIGS. 2I and 2J including a pusher rod;

FIG. 3 illustrates a perspective view of a handle of a bone graftdelivery device including a funnel for introduction of bone graft;

FIGS. 4A-4E are section views illustrating operation of an exampleembodiment of a ratcheting mechanism in a handle of a bone graftdelivery device;

FIGS. 4F and 4G illustrate exploded views of an example embodiment of abone graft delivery device including a ratcheting mechanism;

FIGS. 4H-4M illustrate operation of the ratcheting mechanism of thedevice of FIGS. 4F and 4G;

FIG. 4N illustrates a perspective view of an example embodiment of abone graft delivery device including a ratcheting mechanism;

FIG. 4O illustrates an exploded view of the bone graft delivery deviceof FIG. 4N;

FIGS. 4P-4T are section views illustrating operation of the ratchetingmechanism of the device of FIGS. 4N and 4O;

FIGS. 4U and 4V illustrate section views of an example embodiment of ahandle of a bone graft delivery device including a ratcheting mechanism;

FIG. 4W illustrates a radiopaque ring configured to be placed on adistal end of a tube of a bone graft delivery device;

FIG. 4X illustrates a section view of a distal end of a plunger of abone graft delivery device;

FIGS. 5A and 5B illustrate an example embodiment of a bone graftdelivery device having a modular handle and tube construction;

FIGS. 6A-6C illustrate various views of a distal tip of the bone graftdelivery device of FIGS. 1A and 1B;

FIG. 6D illustrates a perspective view of an example embodiment of abone graft delivery device having a curved tube;

FIG. 6E illustrates a perspective view of an example embodiment of abone graft delivery device having a straight tube;

FIG. 6F illustrates an enlarged view of a rasping distal tip of the bonegraft delivery device of FIG. 6E;

FIG. 6G illustrates the distal tip of FIG. 6F extruding bone graftmaterial;

FIG. 6H illustrates an example embodiment of a rasping distal tipcoupled to a tube of a bone graft delivery device;

FIG. 6I illustrates the distal tip of FIG. 6H extruding bone graftmaterial;

FIG. 7A illustrates a perspective view of an example embodiment of abone graft delivery device;

FIG. 7B illustrates a perspective view of an example embodiment of abone graft delivery device including a shaft having a distal burrdisposed therethrough;

FIG. 7C illustrates an enlarged view of the distal end of the bone graftdelivery device of FIG. 7B;

FIG. 8A illustrates a distal section of an example embodiment of a bonegraft delivery device including an endoscope;

FIG. 8B illustrates a distal section of another example embodiment of abone graft delivery device including an endoscope;

FIGS. 9A and 9B illustrate the bone graft delivery device of FIGS. 2Aand 2B with a guide bracket for a surgical navigation system;

FIGS. 10A-10E illustrate a bone graft delivery device configured todeliver bone graft to an interbody device;

FIG. 11A illustrates a perspective view of an example embodiment of aninterbody device configured to be coupled to a bone graft deliverydevice;

FIG. 11B illustrates a side view of the interbody device of FIG. 11A;

FIG. 11C illustrates a section view of the interbody device of FIGS.11A-11B taken along line 11C-11C in FIG. 11B;

FIG. 11D illustrates a top view of the interbody device of FIGS.11A-11C;

FIG. 11E illustrates a bone graft delivery device coupled to theinterbody device of FIGS. 10A-10D disposed within a disc space and bonegraft spreading to the surrounding disc space from inside the interbodydevice;

FIG. 12 illustrates an example embodiment of an expandable interbodydevice coupled to a bone graft delivery device;

FIG. 13 illustrates an example embodiment of a bone graft deliverysystem kit;

FIG. 14 illustrates an example embodiment of an attachment membercoupling a tube of a bone graft delivery device to an interbody cage;

FIGS. 15A-15B illustrate example embodiments of applicators configuredto be coupled to a tube of a bone graft delivery device to direct bonegraft material in various directions;

FIG. 16A illustrates a side view of an example embodiment of a bonegraft delivery device having a handle including a trigger and aratcheting mechanism with the trigger in a first position;

FIG. 16B illustrates a section view of the bone graft delivery device ofFIG. 16A;

FIG. 16C illustrates a side view of the bone graft delivery device ofFIG. 16A with the trigger in a second position;

FIG. 16D illustrates a section view of the bone graft delivery device ofFIG. 16C;

FIG. 17A illustrates a perspective view of an example embodiment of abone graft loading device;

FIG. 17B illustrates a section view of the bone graft loading device ofFIG. 17A;

FIG. 17C illustrates an exploded view of the bone graft loading deviceof FIGS. 17A-17B;

FIG. 17D illustrates a perspective view of another example embodiment ofa bone graft loading device;

FIG. 17E illustrates a side view of the bone graft loading device ofFIG. 17D;

FIG. 17F illustrates an exploded view of the bone graft loading deviceof FIGS. 17D-17E;

FIG. 18A illustrates an exploded view of another example embodiment of abone graft loading device;

FIG. 18B illustrates a tube body and base of the bone graft loadingdevice of FIG. 18A;

FIG. 18C illustrates a plunger of the bone graft loading device of FIG.18A; and

FIG. 18D illustrates a cap or coupling of the bone graft loading deviceof FIG. 18A.

DETAILED DESCRIPTION

As shown in FIGS. 1A and 1B, an example embodiment of a bone graftdelivery device 100 generally includes a handle 102 having a trigger 110or other actuation mechanism, a tube 120 having a lumen therethrough,and a distal tip 130. In the illustrated embodiment, the bone graftdelivery device 100 is similar to a caulking gun. The handle 102 canhouse a supply of the desired bone graft material. The bone graftmaterial can be pre-loaded in the handle 102 or tube 120 or can besupplied to the handle, for example, via a cartridge that can beremovably coupled to the handle 102. In some embodiments, the device 100can further include a plunger 112 that is retracted proximally to allowthe handle to receive a cartridge or pre-loaded volume of bone graftmaterial. In some embodiments, for example as shown in the exampleembodiment of FIGS. 2A and 2B, the bone graft delivery device 100 doesnot include a distal tip 130. In some embodiments, the bone graftdelivery device does not include a rasping distal tip as described ingreater detail herein.

In use, the trigger 110 is actuated to deliver bone graft materialthrough the tube 120 and distal tip 130 to a desired surgical location.In some embodiments, the plunger 112 is simultaneously pushed distallyto help deliver bone graft material through the tube 120. In someembodiments, the trigger 110 or other actuation mechanism is configuredto deliver a controlled release amount of bone graft material duringactuation of the device, for example, ½ cc of bone graft material percomplete squeeze of the trigger 110. The trigger 110 or other actuationmechanism may be operated manually or by mechanical, battery powered,electric, pneumatic, or any other means of force.

In some embodiments, a portion of the handle 102 can include an openingconfigured to receive the bone graft material. For example, a base ofthe handle 102 can include a funnel 104 as shown in FIGS. 2A-2B and 3.In other embodiments, a side or another portion of the handle 102 caninclude a funnel 104 or other opening configured to receive the bonegraft material, for example as shown in FIGS. 2C-2K. Whereas someexisting bone graft delivery devices are only compatible with certain,e.g., pre-packaged, bone graft materials, the funnel 104 can be designedto advantageously allow the user to use any bone graft material orcombination of bone graft materials he or she wishes or deemsappropriate. For example, the user can use synthetic, autologous, stemcell, DMB, cadaveric, and/or any other available bone graft material.The handle 102 can further include a channel or funnel shaft 106extending therethrough connecting and in fluid communication with thefunnel 104 and tube 120. In use, the user can mix the desired bone graftmaterial in the funnel 104, then use the plunger 112 or other means toadvance the bone graft material through the channel 106 and into thetube 120 for delivery.

In some embodiments, the handle 102 includes a ratcheting mechanism 108configured to advance the plunger 112 and bone graft material from thefunnel 104 and through the channel 106 and tube 120 for delivery, asshown in FIGS. 4A-4E. The ratcheting mechanism 108 (or any of theratcheting mechanisms described herein) and plunger 112 canadvantageously create pressure on the bone graft material in the tube120 to improve delivery to the target location. In some embodiments, theplunger 112 fully or substantially seals with the inner diameter of thetube 120. This can create a vacuum within the tube 120 and/or canprovide greater pressure on the bone graft material to force the bonegraft material through the tube 120 and out of the distal end of thetube 120 or distal tip 130. In some embodiments, the plunger 112 or aportion of the plunger 112 is made of, for example, rubber silicone,which can help improve the seal with the tube 120 and/or can helpprovide pressure on the bone graft material. In some embodiments, theplunger 112 can be made of a plastic or another material and can includean elastomeric rubber stopper 115 at the distal end, for example asshown in FIG. 4O. The stopper 115 can be dual injection molded orco-molded with the plunger 112 so that the stopper 115 cannot normallybe removed from the plunger 112. As shown in FIG. 4X, the stopper 115can be molded onto or over a barb-shaped distal end of the plunger 112.The plunger 112 and ratcheting mechanism 108 can therefore allow thebone graft delivery device to extrude even highly viscous and/orgranular bone graft material.

In the illustrated embodiment, the ratcheting mechanism 108 includes acover 105 and a pawl 109 coupled to the trigger 110 via an arm 208. Thefunnel shaft 106 includes a window 107 in a portion of the shaft 106facing the pawl 109. The plunger 112 can be made of a rigid or flexiblematerial. For example, the plunger 112 can be plastic, carbon fiber,metal, or any other suitable material. The plunger 112 includes a seriesof teeth 114 and notches 113 located between the teeth 114 andconfigured to receive the pawl 109. The notches 113 can be generallytriangular. As shown, distal edges of the teeth 114 slope proximallytoward the outer edge of the plunger 112 to allow the pawl 109 to slidealong the distal edges in use. In some embodiments, extending thetrigger 110 away from the handle 102, for example to a positionperpendicular to the handle 102, causes the cover 105 to rest in andclose the window 107 of the funnel shaft 106, as illustrated in FIGS. 4Aand 4B, to allow for loading of the bone graft material through thefunnel 104 into the channel 106. In this position, the pawl 109 restsproximal to the window 107. The plunger 112 can be inserted into thefunnel 104 and channel 106 to advance some or all of the bone graftmaterial past the window 107. Once the bone graft material has beenloaded, the trigger 110 can be moved toward the handle 102 to anintermediate position, as shown in FIG. 4C. This moves the pawl 109distally so that the pawl 109 engages one of the notches 113 on theplunger 112 through the window 107. Movement of the trigger 110 to afinal position closest the handle 102 causes the pawl 109 to movedistally within the window 107 (or away from the funnel 104 and towardthe tube 120), thereby advancing the plunger 112 distally within thechannel 106 to force the bone graft material distally within the channel106 and/or tube 120, as shown in FIGS. 4D and 4E. The trigger 110 can bemoved back to the intermediate position to cause the pawl 109 to slideproximally along the plunger 112 and over one of the teeth 114 to engagea more proximal notch 113. The trigger 110 can be moved between theintermediate position and final position multiple times until the pawl109 has reached the proximal end of the plunger 112. The user canre-load the device 100 as needed during a procedure. The ratchetingmechanism 108 and trigger 110 in combination can advantageously providea mechanical advantage and allow the user to apply a greater force inoperating the bone graft delivery device 100 and/or delivering the bonegraft material compared to, for example, a standard syringe used todeliver bone graft material.

Another example embodiment of a handle 102 and ratcheting mechanism 108is shown in FIGS. 4F-4M. In this embodiment, the handle 102 includes atwo-part clamshell housing 102 a, 102 b that houses the funnel 104,funnel shaft 106, and ratcheting mechanism 108 assembly as shown in theexploded views of FIGS. 4F and 4G. The ratcheting mechanism 108 includesthe pawl 109 and a sheath 205 coupled to the trigger 110 via arm 208.The plunger 112 includes a series of sloped teeth 114 alternating withnotches 113 that are configured to receive the pawl 109. When thetrigger 110 is in the first position, as shown in FIGS. 4H and 4I, thesheath 205 covers the pawl window 107 and the pawl 109 rests proximal tothe window 107. Movement of the trigger 110 to the intermediate positioncauses the sheath 205 and pawl 109 to move distally, exposing the window107 and allowing the pawl 109 to engage the plunger 112, as shown inFIGS. 4J and 4K. Movement of the trigger 110 to the final positioncauses the pawl 109 to move distally, advancing the plunger 112distally, as shown in FIGS. 4L and 4M.

Yet another example embodiment of a handle 102 and ratcheting mechanism108 is shown in FIGS. 4N-4T. In this embodiment, the funnel shaft 106includes an upper shaft portion 106 a and a lower shaft portion 106 b,and the lower shaft portion 106 b has an outer diameter smaller than anouter diameter of the upper shaft portion 106 a. As shown in FIGS.4P-4T, the outer diameter of the lower shaft portion 106 b can beapproximately the same as an inner diameter of the upper shaft portion106 a, and the shaft 106 can include a step 206 (shown in FIG. 4R) at atransition point between the upper shaft portion 106 a and lower shaftportion 106 b. In the illustrated embodiment, the upper 106 a and lower106 b shaft portions are integrally formed. In other embodiments, theupper 106 a and lower 106 b shaft portions can be separate pieces, and aproximal end of the lower shaft portion 106 b can be coupled to an innerperimeter of a distal end of the upper shaft portion 106 a. The uppershaft portion 106 a includes a first window 107 a for the pawl 109 and asecond window 107 b on an opposite side of the upper shaft portion 106 afrom the first window 107 a. A sheath 305 is disposed within or insidethe upper shaft portion 106 a, and in the illustrated embodiment, alever 308 extends from the trigger 110 and engages the sheath 305through the second window 107 b, as shown in FIGS. 4P-4T.

In some embodiments, the lever 308 is integrally formed with the sheath305. Alternatively, the lever 308 can be coupled to the sheath 305, forexample, with a pin 313. In some embodiments, the lever 308 includes abody 310 having a generally circular or ovular aperture 307, and an arm309 extending from one end of the body 310. The aperture 307 receivesthe funnel shaft 106 so that the body 310 surrounds the upper shaftportion 106 a. The sheath 305 includes a protrusion 311 that can extendthrough or over the second window 107 b when the sheath 305 is disposedin the upper shaft portion 106 a. The protrusion 311 is aligned with thelever body 310 with the protrusion 311 disposed in the aperture 307. Thepin 313 extends through holes in the body 310 and protrusion 311 tocouple the sheath 305 to the lever 308. In some embodiments, the pin 313is secured to the protrusion 311 and lever body 310 with a weld, glue,or other appropriate means. The free end of the arm 309 of the lever 308releasably engages the trigger 110. For example, the trigger 110 caninclude a track 116 configured to releasably receive the arm 309 asshown in FIGS. 4P and 4Q, and the arm 309 can engage the track 116 via,for example, a snap fit. In some embodiments, the trigger 110 is biasedor naturally rests at a distance from the handle body that holds the arm309 in the track 116. The trigger 110 can be flexed or allowed to moveslightly away from the handle body to release the arm 309.

In some embodiments, the sheath 305 has an outer diameter about the sameand slightly less than the inner diameter of the upper shaft portion 106a and a thickness about the same as a thickness of the lower shaftportion 106 b. The sheath 305 can include an upper lip 306, and a lengthof the sheath 305 can be selected such that in an initial loadingposition, shown in FIG. 4P, the lip 306 rests against an inner surfaceof the funnel 104 and a distal end of the sheath 305 rests against thestep 206. In the loading position, the sheath 305 covers the firstwindow 107 a. The dimensions of the upper shaft portion 106 a, lowershaft portion 106 b, and sheath 305 advantageously allow the sheath 305to be substantially flush with an inner surface of the upper shaftportion 106 a and step 206 and provide a substantially smooth andconstant-diameter inner passageway from the sheath 305 to the lowershaft portion 106 b. The bone graft delivery device of FIGS. 4N-4T alsoincludes a pusher rod 312 and a tube end cap 124.

To load bone graft material, the lever 308 is coupled to the trigger 110so that the sheath 305 sits in the initial loading position shown inFIG. 4P. Bone graft material 10 is loaded into the funnel 104, and thepusher rod 312 can be inserted into the funnel 104 to help urge the bonegraft material 10 through the sheath 305 and lower shaft portion 106 band into the tube 120 as shown in FIG. 4Q. In some embodiments, thepusher rod 312 is made of, for example, a glass filled or rigid polymermaterial. The tube end cap 124 inhibits or prevents the bone graftmaterial 10 from exiting the distal end of the tube 120 during theloading process and until the user wishes to deliver the bone graftmaterial 10. The tube end cap 124 can be attached to the distal end ofthe tube 120 via a threaded coupling, friction fit, or other suitablemeans. In the illustrated embodiment, the tube 120 includes externalthreads 125 b at or near the distal end configured to mate with internalthreads in the tube end cap 124. Once the bone graft material 10 isloaded, the pusher rod 312 is removed, and the lever 308 is releasedfrom the trigger 110 as shown in FIG. 4R. As shown, release of the lever308 causes or allows the lever to move toward the funnel, thereby alsomoving the sheath 305 proximally to expose the first window 107 a andallow the pawl 109 to enter the shaft 106 through the first window 107a. The plunger 112 can be inserted before or after releasing the lever308 and extends through the sheath 305, upper shaft portion 106 a, andlower shaft portion 106 b and into the tube 120 as shown in FIG. 4S.When the plunger 112 is inserted and the lever 308 is released so thatthe first window 107 a is exposed, the pawl 109 engages one of thenotches 113 on the plunger 112. The lever 308 can advantageously providethe user with a greater mechanical advantage and/or greater control inmoving the sheath 305 proximally to expose the first window 107 a. Inother embodiments, the sheath includes a protrusion 316 without a leveras shown in FIGS. 4U and 4V. The user can use the protrusion 316 to liftor lower the sheath 305.

The tube end cap 124 is removed when the user wishes to deliver the bonegraft material 10 through the tube 120. Movement of the trigger 110toward the handle causes the pawl 109 to move distally, advancing theplunger 112 distally, as shown in FIG. 4T. The trigger 110 is moved awayfrom and toward the handle to advance the plunger 112 and bone graftmaterial 10 through the tube 120 in discreet increments. Of course,other ratcheting mechanisms and/or other mechanisms for advancing bonegraft material through the handle 102 and/or tube 120 are also possible.

In some embodiments, the funnel 104 or other opening for loading of bonegraft material can be positioned in the handle 102 in locations otherthan a proximal end or base of the handle 102. For example, in theexample embodiment of FIGS. 2C-2E, the handle 102 is configured suchthat the trigger 110 and a grip 111 extend from a main body portion 103of the handle 102. As shown, the funnel 104 is located on an oppositeside of the body portion 103 from the grip 111 and trigger 110. A mainchannel 406 extends through the handle 102 from an opening in a proximalend of the body portion 103 to an opening in a distal end of the bodyportion 103 and is in fluid communication with the tube 120. The funnelshaft 106 extends from the funnel 104 to intersect the main channel 406as shown in FIGS. 2D and 2E. In the illustrated embodiment, the funnel104 and funnel shaft 106 are oriented at an angle 1 relative to the mainchannel 406. The angle can advantageously help direct bone graftmaterial inserted into the funnel 104 and funnel shaft 106 distallytoward the tube 120. The bone graft delivery device can include a pusherrod 312 as shown in FIG. 2E to help urge bone graft material from thefunnel 104 through the funnel shaft 106 and into the main channel 406.In some embodiments, the pusher rod 312 can be configured such that whenfully inserted into the funnel 104 and funnel shaft 106, a distal end314 of the pusher rod 312 rests at the intersection of the funnel shaft106 with the main channel 406 to at least partially or substantiallyclose the main channel 406. The distal end 314 of the pusher rod 312 canbe formed at an angle with the angle corresponding to the angle of thefunnel shaft 106 so that the distal end 314 is continuous with a wall ofthe main channel 406 when inserted into the funnel shaft 106. In suchembodiments, the pusher rod 312 can be configured to remain in placeduring delivery of bone graft material.

The handle 102 of FIGS. 2C-2E can include any of the ratchetingmechanisms described herein or any other suitable ratcheting mechanism.In use, once the bone graft material is loaded via the funnel 104, theplunger 112 is inserted from the proximal opening of the main channel406 through the handle 102 and into the tube 120. The main channel 406can include a window to allow the pawl to engage notches on the plunger.In use, movement of the trigger 110 toward the grip 111 can cause thepawl to advance the plunger and bone graft material distally in the tube120. Releasing the trigger 110 to allow the trigger 110 to move awayfrom the grip 111 causes the pawl to slide proximally along the plungerto engage a more proximal notch. If the window is located proximal tothe intersection of the funnel shaft 106 with the main channel 406, thecover, sheath, or the like can be omitted from the ratcheting mechanism.In such embodiments, the bone graft material does not pass through theportion of the main channel 406 having the window, so the window can beleft uncovered during loading. In some embodiments, the handle 102 ofFIGS. 2C-2E does not include a ratcheting mechanism, and a plunger canbe inserted into and advanced through the main channel 406 and tube 120to advance and deliver the bone graft material.

FIGS. 2F-2H illustrate an alternative embodiment in which the funnel 104is located on the same side or surface of the handle 102 as the trigger110. In the illustrated embodiment, the funnel 104 is advantageouslylocated distal to the trigger 110 so that the pusher rod 312, wheninserted into the funnel 104, does not interfere with operation of thetrigger 110. The embodiment of FIGS. 2F-2H can also include a mainchannel 406, an angled funnel 104, funnel shaft 106, and distal end 314of the pusher rod 312, and any suitable ratcheting mechanism similar tothe embodiment shown in FIGS. 2C-2E and discussed above. In use, aplunger is inserted into the main channel 406 and tube 120. In theillustrated embodiment, the main channel 406 includes a window 107 toallow the pawl 109 to engage notches on the plunger when the plunger isinserted. Movement of the trigger 110 towards the handle 102 causes thepawl 109 to move distally within the window 107, thereby advancing theplunger and bone graft material. Movement of the trigger 110 away fromthe handle causes the pawl 109 to slide proximally along the plunger andengage a more proximal notch. In the illustrated embodiment, the window107 and ratcheting mechanism are located proximal to the intersection ofthe funnel shaft 106 with the main channel 406, and the ratchetingmechanism does not include a cover or sheath. FIGS. 2I-2K illustrateanother alternative embodiment, similar to the embodiment of FIGS.2F-2H, with the funnel 104 positioned on a side or surface of the handle102 lateral or generally perpendicular to the trigger 110. In otherembodiments, the funnel 104 can be located on any side or surface of thehandle 102, for example, opposite the trigger 110, to either side of thetrigger, or any other position around the handle 102. The funnel 104 canalso be located distal to, even with, or proximal to the trigger 110.

FIGS. 16A-16D illustrate another alternative embodiment of a bone graftdelivery device 100 having a handle 102 including a ratcheting mechanism508. In use, the ratcheting mechanism 508 is used to advance the plunger112 and bone graft material through the tube 120 for delivery. As shown,the ratcheting mechanism 508 includes a pawl 509 having one or moreteeth 514 that are received in the notches 113 of the plunger 112. Inthe illustrated embodiment, the pawl 509 includes four teeth 514,although more or fewer teeth 514 are also possible. A pawl 509 havingmultiple teeth 514 can engage multiple notches 113 of the plunger 112simultaneously, which can advantageously provide a more secureengagement between the ratcheting mechanism 508 and the plunger 112,allow the pawl 509 to apply a greater advancement force on the plunger112, and/or compensate for possible malfunctioning or manufacturingvariances or defects to better ensure at least one tooth 514 engages theplunger 112.

The pawl 509 can be coupled to the trigger 110 via a pivot point 515and/or a spring 517. The spring 517 can advantageously provideresistance to movement of the trigger 110 relative to the body of thehandle 102. In some embodiments, the spring 517 can bias the trigger 110away from the body of the handle 102 (toward the position shown in FIGS.16A-16B).

In some embodiments, the handle 102 and tube 120 have a modularconstruction such that the tube 120 is removably coupleable to thehandle 102 as described herein. The tube 120 can be provided preloadedwith bone graft or can be loaded with bone graft prior to being coupledto the handle 102 as described in greater detail herein. In someembodiments, a handle 102, for example, a handle 102 including any ofthe ratcheting mechanisms described herein or another suitableratcheting or advancement mechanism, need not include a funnel and/or achannel or funnel shaft. In use, a tube 120 loaded with bone graft iscoupled to the handle 102, the plunger 112 is inserted through thehandle 102 into the tube 120, and the ratcheting mechanism 508 is usedto advance the plunger 112 and bone graft material through the tube 120for delivery.

In use, movement of the trigger 110 from the position shown in FIGS.16A-16B to the position closest to the handle 102 body shown in FIGS.16C-16D causes the teeth 514 of the pawl 509 to move distally (towardthe tube 120) within the handle 102, thereby advancing the plunger 112distally within the tube 120 to force the bone graft material distallywithin the tube 120. Movement of the trigger 110 back to the positionshown in FIGS. 16A-16B causes the teeth 514 of the pawl 509 to sideproximally along the plunger 112 and over the teeth 114 to engage moreproximal notches 113.

In some embodiments, the plunger 112 teeth 114 can be spaced relativelycloser together (for example, as shown in FIGS. 16A-16B compared to FIG.4I). Such closer spacing can allow the ratcheting mechanism 108, 508 tobe more reliable such that in the event that the pawl 509 misses a notch113, the pawl 509 can engage the next notch 113 more quickly, easily,and/or with less backlash. The closer spacing can also allow the user tosqueeze the trigger 110 toward the handle 102 body to a lesser extent(for example, only halfway or to another intermediate point) to delivera smaller amount of bone graft material at a particular time if desired.If the distance between the teeth 114 is less than the displacement ofthe plunger 112 with a full stroke of the trigger 110 and ratchetingmechanism 108, 508, the pawl 109, 509 can engage a more proximal notch113 as long as the trigger 110 is moved toward the handle 102 bodyenough that the plunger 112 is displaced by a distance greater than thedistance between adjacent notches 113.

As shown in FIGS. 1A and 1B, the tube 120 of any of the devicesdescribed herein can include a permanent bend or curve that may beuseful in positioning the device 100 at a desired location, for example,a space between two spinal discs, transverse process, facet joint,lamina, or other target area. Alternatively, the tube 120 may bestraight, for example, as shown in FIGS. 2A and 2B, to deliver bonegraft material directly into a desired location such as a disc space,transverse process, facet joint, lamina, or other target area. In someembodiments, the tube 120 is somewhat flexible or repositionable and canbe manipulated to bend or curve the tube 120 as needed to reach thedesired location. In some embodiments, the tube 120 is made of a rigidmaterial, for example, a plastic, composite, or metal. In someembodiments, the tube 120 can be at least partially transparent, whichcan allow the user to view, for example, the volume or position of thegraft material within the tube 120. The tube 120 can also include volumemarkings to allow the user to monitor the amount of graft materialdelivered to the target site and remaining in the tube 120, for example,as shown in FIGS. 4N-4O. In some embodiments, the tube 120 includes oneor more radiopaque markers to allow for visualization on, for example,x-ray or fluoroscopy. The tube 120 is generally hollow to allow for thepassage of bone graft material through the lumen of the tube 120. Thetube 120 and lumen can have various diameters, for example, fordifferent applications and/or target locations.

In some embodiments, the tube 120 can be integrally formed with orpermanently coupled to the handle 102. In other embodiments, the bonegraft delivery device 100 can have a modular construction so thatvarious tubes 120 can be selected and coupled to the handle 102. Such amodular construction can advantageously allow the user to interchangestraight and curved handles and/or handles having various other featuresdepending on the target location, particular patient, and/or otherfactors. As shown in FIGS. 5A and 5B, the distal end of the handle 102or any of the handles described herein can include a recess 60configured to receive a base 62 coupled to or integrally formed with thetube 120. The base 62 can be coupled to the tube 120 via a threadedcoupling, press fit, or any other suitable means. For example, in theembodiment shown in FIGS. 4N-4T, the tube 120 includes external threads125 a at or near a proximal end of the tube configured to mate withinternal threads in the base 62. As shown in FIG. 5B, the base 62 caninclude an aperture to allow fluid communication between the funnelshaft 106 in the handle 102 and the tube 120. The tube 120 can also becoupled to the handle 102 by any other appropriate means.

As shown in FIGS. 6A-6C, a distal end of the tube 120 (which may be anyof the tubes described herein) can include a tip 130. The tip 130 can beintegrally formed with or coupled, removably or permanently, to the tube120. In some embodiments, the tube 120 and tip 130 can be a modularsystem such that different tips can be selected and coupled to the tube120 for different procedures and/or target locations. The tip 130 can bemade of a metallic, radiopaque material to facilitate visualization on,for example, fluoroscopy or x-ray. Alternatively, the tip 130 may bemade of another material, for example a durable medical plastic or acomposite material, and may include markers to facilitate visualization.In the illustrated embodiment, the tip 130 is somewhat bullet-shapedwith a generally triangular cross-section; however, other shapes andconfigurations are also possible. For example, the tip 130 can begenerally flat as shown in the example embodiments of FIGS. 6D-6G. Insome embodiments, for example as illustrated in the example embodimentof FIG. 6H-6I, the tip 130 is generally conical. This shape can bebeneficial for delivering bone graft material to, for example, a facetjoint. In some embodiments, the tip 130 is pointed and/or sharp todissect or split muscle and tissue as it is advanced through thepatient's skin and body to the surgical location. Alternatively, the tip130 can be blunt to allow for displacement of muscle without risk ofcutting of nerves or other tissue. The tip may have a single or multipleopenings 132 in fluid communication with the tube 120 lumen andconfigured to deliver the bone graft material 10 from the tube 120, asshown in FIG. 6G, to the desired location.

In some embodiments, at least one side or area of the tip 130 includes aseries of jagged edges or other suitable surface 134 configured to serveas a rasp for scraping bone. As shown in FIGS. 6A and 6C, the edges maybe triangular in shape, and as shown in in FIGS. 6D-6G, they may beflat. With respect to the embodiment shown in FIGS. 6D-6G, the jaggededges may form a plurality of flat surfaces parallel with each other allwithin the same plane. In some embodiments, for example as shown inFIGS. 6H-6I, the rasping surface 134 can include a roughened surfaceextending around an outer surface of the tip. The rasp may be operatedmanually or by mechanical, battery powered, electric, pneumatic, or anyother means of force to allow for decortication of the area to receivethe bone graft material. In some embodiments, the opening(s) 132 fordelivering bone graft material is located on a side(s) or portion(s) ofthe tip 130 that does not include a rasping surface, for example asshown in FIGS. 1A-1B and 6A-6C. In some embodiments, the opening(s) 132is located on a side(s) or portion(s) that does include a raspingsurface, for example as shown in FIGS. 6D-6I and 8A.

In some embodiments, the delivery device 100 includes a sleeve slidablyor telescopingly disposed over the tip 130. In some embodiments, thesleeve can extend to a proximal end of the tube 120 adjacent the handle102 so that a user can distally advance or proximally retract the sleeveby manipulating a proximal end of the sleeve. In other embodiments, thesleeve extends over only a portion of the tube 120 or over only the tip130 and the delivery device 100 includes an actuating mechanism thatallows the sleeve to be advanced and retracted. The sleeve can bedisposed over the tip 130 during insertion of the tip 130 to the targetarea to advantageously protect skin, tissue, and/or muscle along theinsertion path from damage or injury from the rasping surface 134 and toallow the tip 130 to pass through the skin, tissue, and/or muscle moreeasily. Once the tip is positioned in the target location, the sleevecan be proximally retracted to expose the rasping surface 134 fordecortication of the target area. After decortication and/or afterdelivery of the bone graft material, the sleeve can be distally advancedto cover the rasping surface 134 for withdrawal of the tip 130 from thebody.

In some embodiments, the distal end of the tube 120 does not include arasping tip 130, for example as shown in FIGS. 7A-7C. In some suchembodiments, an elongate shaft 150 having a burr 152 at a distal end canbe inserted through the tube 120 as needed or desired to decorticate atarget area, for example as shown in FIGS. 7B and 7C. The burr 152 canhave various shapes and configurations, for example, a generallyspherical shape as shown in FIGS. 7B and 7C, a bullet shape similar tothe distal tip 130 shown in FIGS. 6A-6C, a generally flat shape similarto the distal tip 130 shown in FIGS. 6D-6G, a generally conical shape asshown in FIGS. 6H-6I, or any other suitable shape or configuration. Theuse of a separate instrument for decortication can advantageously allowthe user to select different burrs, rasps, or the like for differentpatients, target areas, or situations. The elongate shaft 150 and burr152 can be operated manually. Alternatively, a proximal end of the shaft150 can be coupled to a drill 154 or another device to providedecortication by mechanical, battery powered, electric, pneumatic, orany other means of force.

In some embodiments, the distal end of the tube 120 includes aradiopaque ring or other marker 122 as shown in FIG. 7C to allow forvisualization on, for example, x-ray or fluoroscopy. In someembodiments, the radiopaque ring 122 can be used to assist the user inassessing depth during the procedure. In some embodiments, for exampleas shown in FIG. 4O, the radiopaque ring 122 can be press fit or snappedonto the distal end of the tube 120 during manufacturing and assembly.In some embodiments, for example as shown in FIG. 4W, the radiopaquering 122 can be press fit or snapped into a groove 222 near a distal endof the tube 120. In the illustrated embodiment, the groove 222 is distalto the threads 125 b configured to receive the tube end cap 124 and istherefore covered by the tube end cap 124 when the tube end cap 124 iscoupled to the tube 120. In some embodiments, the radiopaque ring 122can be co-molded with the tube 120 during manufacturing.

In some embodiments in which the handle 102 and tube 120 have a modularconstruction such that the tube 120 is removably coupleable to thehandle 102, the tube 120 can be provided preloaded or can be loaded witha loading device prior to being coupled to the handle 102. FIGS. 17A-18Dshow example embodiments of loading devices 600 for loading bone graftmaterial into the tube 120. Such loading devices 600 can allow the userto load the tube 120 with any bone graft material or combination of bonegraft materials he or she wishes or deems appropriate. For example, theuser can use synthetic, autologous, stem cell, DMB, cadaveric, and/orany other available bone graft material.

As shown in the embodiments of FIGS. 17A-17F, the loading devices 600include a hollow tube body 602, a plunger shaft 604, a plunger 605, anda cap or coupling 608. In some embodiments, the tube body 602 can hold avolume of about 20 cc, although other sizes and volume are alsopossible. The tube body 602 can have a smooth or generally smooth innerwall. In some embodiments, the tube body 602 includes measurementmarkings to allow the user to determine the amount of bone graftmaterial within the tube body 602. The tube body 602 includes a distaltip or end 610. As shown, the distal tip 610 has a smaller diameter thanthe tube body 602. The tube 120 of a bone graft delivery device 100 suchas those described herein is coupled to the distal tip 610 for loading.In some embodiments, the distal tip 610 is internally threaded toreceive and engage external threads 125 a at or near the proximal end ofthe tube 120 (shown in FIG. 4O). In some embodiments, the plunger 605 ismade in part or entirely of rubber. The plunger 605 is coupled, eitherremovably or permanently, to a distal end of the plunger shaft 604. Insome embodiments, the plunger shaft 604 and plunger 605 are integrallymolded or formed. The plunger 605 has a greater diameter than theplunger shaft 604 and is sized and shaped to contact and seal againstthe inner wall of the tube body 102. In some embodiments, the loadingdevice 600 includes a handle 606 that allows the user to better grip theplunger shaft 604. As shown, the handle 606 is integrally molded orformed or coupled, either removably or permanently, to a proximal end ofthe plunger shaft 604. The handle 606 can have various shapes andconfigurations, for example as shown in the embodiments of FIGS. 17A-17Cand 17D-17F.

As shown, the plunger shaft 604 is externally threaded. The cap orcoupling 608 couples to a proximal end of the tube body 602, forexample, via a threaded, snap-fit, or other suitable connection. In someembodiments, the cap 608 couples to the tube body 602 via a combinedsnap fit and rotational coupling mechanism whereby the cap 608 isattached to the tube body 602 by rotating the cap 608 (e.g., clockwise)until the cap 608 snaps into place; the cap 608 can be removed from thetube body 602 by rotating the opposite direction (e.g., counterclockwise) to disengage the snap fit and rotating until the cap 608fully releases from the tube body 602. The cap 608 has a through-holethat is sized to receive the plunger shaft 604 therethrough andinternally threaded to engage the external threads of the plunger shaft604. The cap 608 can be predisposed on the plunger shaft 604. The cap608 can be threaded along the plunger shaft 604, but can be retained onthe plunger shaft 604, which has a larger diameter than the plungershaft 604 and therefore a larger diameter than the through-hole in thecap 608 that is sized to engage the plunger shaft 604.

In some embodiments, for example as shown in the embodiment of FIG.17A-17C, the tube body 602 includes handles or wings 612 extendinggenerally laterally outwardly from the tube body 602. The wings 612 canadvantageously allow the user to grip the tube body 602 more easily andsecurely in use. The wings 612 can have various shapes andconfigurations as shown.

In use, the user can couple the tube 120 of the bone graft deliverydevice 100 to the distal tip 610 of the loading device 600 before orafter loading the desired bone graft material into the tube body 602. Ifneeded, the user threads the cap 608 to the distal end of the plungershaft 604 proximate the plunger 605. The user then inserts the plunger605 into the tube body 602 and couples the cap 608 to the proximal endof the tube body 602. To transfer the bone graft material from the tubebody 602 to the tube 120, the user rotates the plunger shaft 604 (e.g.,clockwise), for example, by rotating the handle 606, into the cap 608.The internally threaded cap 608 converts the rotational motion of theexternally threaded plunger shaft 604 relative to the cap 608 intotranslational motion of the plunger shaft 604 and plunger 605 distallywithin the tube body 602. Distal motion of the plunger 605 forces thebone graft material through the distal tip 610 and into the tube 120.The threaded coupling between the plunger 605 and the cap 608advantageously allows the user to apply greater torque compared to asyringe-type arrangement wherein the plunger is simply pushed distallywithin the tube body. This greater torque allows the bone graft materialto be loaded into the tube 120 more easily. When a desired amount ofbone graft material has been loaded into the tube 120, the user canremove the tube 120 from the loading device 600 and couple the tube 120to a handle 102 for use. If needed during the course of a procedure, thetube 120 can be decoupled from the handle 102, reloaded with the loadingdevice 600, then decoupled from the loading device 600 and recoupled tothe handle 102 to continue the procedure.

FIGS. 18A-18D illustrate an alternative embodiment of a loading device700. The loading device 700 similarly includes a tube body 702, anexternally threaded plunger shaft 704, a plunger 705, and an internallythreaded cap or coupling 708 that couples to a proximal end of the tubebody 702. As shown in FIG. 18D, the cap 608 can include an internallythreaded proximal ring 722 and two arms 724 extending distally from theproximal ring 722 on opposite sides of the proximal ring 722. Distalends of the arms 724 can include hooks to secure the cap 608 to the tubebody 702. Other shapes and configurations for the cap 708 are alsopossible. As shown in FIG. 18C, a plunger stop 720 can be disposed aboutthe plunger shaft 704 proximate the distal end of the plunger shaft 704and the plunger 705. As shown in FIG. 18A, the proximal ring 722 of thecap 708 is disposed about the plunger shaft 704 proximal to the plungerstop 720. The plunger stop 720 can help prevent or inhibit the cap 708from falling off the plunger shaft 704. In the illustrated embodiment,the loading device 700 also includes a handle 706 at the proximal end ofthe plunger shaft 704. The handle 706 can be integrally formed with theplunger shaft 704 as shown or can be coupled, removably or permanently,to the plunger shaft 704. In the illustrated embodiment, the tube body702 includes a side spout 714 extending laterally from a side of thetube body 702 and in fluid communication with the internal volume of thetube body 702.

In some embodiments, the loading device 700 includes a base 716, whichcan advantageously allow the loading device 700 to stand on a table orother support surface before, during, or after use. In some embodiments,the loading device 700 includes a tube stop 718 that fills the internalvolume of the tube body 702 between the distal end or bottom of the tubebody 702 and the side spout 714. In the illustrated embodiment, the tubestop 718 extends proximally within the tube body 702 to a point proximalto a distal side of the side spout 714. This can help encourage as muchbone graft material as possible to travel through the side spout 714 tothe tube 120 and reduce potential waste of bone graft material settlinginto a distal end of the tube body 702 distal to or below the side spout714. In some embodiments, the tube stop 718 can be made of a materialthat adds some weight to the bottom of the tube body 702 toadvantageously provide the tube body 702 with greater stability whenplaced on a table or other surface.

The loading device 700 operates similarly to the loading devices 600described above. However, in this embodiment, the tube 120 of the bonegraft delivery device 100 is coupled to the side spout 714 for loading,and advancement of the plunger shaft 704 and plunger 705 distally withinthe tube body 702 forces the bone graft material within the tube body702 through the side spout 714 and into the tube 120.

In some embodiments, the bone graft delivery device 100 can beconfigured to deliver bone graft material inside an interbody cage orother interbody device that has been disposed within a disc space. Ifsufficient bone graft is not applied to a disc space during a fusionprocedure, there is a decreased likelihood of fusion and an increasedchance of revision surgery. Some interbody implants or cages include anopening or window that can be filled with bone graft. However, thisprovides for limited surface area for the bone graft to contact thevertebral end plates. In some cases, surgeons use funnels or similardevices to fill the disc space prior to insertion of the implant.However, inserting an interbody cage after delivering bone graftmaterial can disrupt the placement of the bone graft material.Furthermore, it can be difficult to deliver bone graft to the disc spacein a controlled manner after the implant has been inserted, and it canbe difficult for the surgeon to access the desired area to deliver thebone graft if the implant is already in place. Delivering the bone graftmaterial after inserting the interbody cage and inserting the bone graftmaterial within the interbody cage can help ensure the bone graftmaterial is placed where desired or required. The bone graft deliverydevice 100 allows for pressurized and controlled delivery of bone graftmaterial into the cage to maximize filling of the cage with the bonegraft material.

In some embodiments, an attachment member can be provided to couple thedistal end of the tube 120 of the bone graft delivery device 100 to theinterbody cage. Bone graft material is delivered through the tube 120and attachment member and into the interbody cage. FIG. 14 illustratesan example embodiment of an attachment member 800 that can couple thedistal end of the tube 120 to an interbody cage 401. A proximal end ofthe attachment member 800 is sized and configured to couple to thedistal end of the tube 120, and the distal end of the attachment member800 is sized and configured to couple to the interbody cage 401. In someembodiments, the proximal end of the attachment member 800 can beinternally threaded to engage external threads 125 b at the distal endof the tube 120. In other embodiments, the attachment member 800 cancouple to the tube 120 via a snap fit or another suitable connectionmechanism. Various attachment members can be manufactured and/orprovided for use with various interbody cages or other interbodydevices.

In some embodiments, the distal end of the tube 120 itself includesfeatures configured to engage corresponding features on an interbodydevice. FIGS. 10A-10E illustrate an example embodiment of a tube 120having a distal end 122 configured to engage an interbody cage 400. Thedistal end 122 of the tube 120 can be coupled to the cage 400 after thecage 400 has been placed in the disc space as shown in FIGS. 10A and10B. As shown in FIG. 10D, the distal end 122 of the tube 120 includesalternating ridges 121 and recesses 123 configured to mate withcorresponding recesses 404 and ridges 402 on the cage 400. In some suchembodiments, various tubes 120 with different engagement features can bemanufactured and/or provided for use with various interbody devices, andthe user can select the appropriate tube 120 after selecting theinterbody device to be used. In various embodiments, the tubes 120and/or attachment members can be configured to couple to various cagesvia threaded connections, snap fit connections, clip-on connections,wedge connections, and/or any other suitable connection mechanism. Insome embodiments, the tubes 120 and/or attachment members can beconfigured to abut one or more cages without such a connectionmechanism.

FIGS. 15A-15B illustrate example embodiments of applicators 850 a, 850 bthat can be coupled to the distal end of the tube 120 to direct bonegraft in various directions. For example, in some embodiments, theapplicators 850 a, 850 b allow bone graft material to be directed arounda cage disposed within the disc space. A proximal end of the applicator850 a, 850 b couples to the distal end of the tube 120. In someembodiments, the proximal end of the applicator 850 a, 850 b isinternally threaded to engage external threads 125 b at the distal endof the tube 120. In other embodiments, the applicator 850 a, 850 b cancouple to the tube 120 via a snap fit or another suitable connectionmechanism. The applicators 850 a, 850 b can have various shapes. FIG.15A illustrates an applicator 850 a having an approximately 90° curveproximate the distal end such that bone graft material can be extrudedin a direction approximately 90° from the distal end of the tube 120.FIG. 15B illustrates an applicator 850 b having an S-shape or serpentineshape. In the illustrated embodiment, the applicator 850 b allows thebone graft material to be extruded along a direction generally parallelbut offset from the distal end of the tube 120. Other shapes andconfigurations, for example, various curved and/or angular shapes, arealso possible.

Example embodiments of cages that can be used with the bone graftdelivery device 100 are illustrated in FIGS. 11A-12. In the embodimentof FIGS. 11A-11D, the cage 400 has a leading end 410, a trailing end412, and first and second sidewalls 414, 416 extending between theleading end 410 and trailing end 412. In the illustrated embodiment, theleading end 410 is tapered or generally wedge-shaped. The sidewalls 414,416 have an upper bone contacting surface 418 configured to contact asuperior vertebra and a lower bone contacting surface 420 configured tocontact an inferior vertebra. The cage 400 also has a central opening422 bounded by the leading end 410, trailing end 412, and sidewalls 414,416 and an opening 424 in the trailing end that is in fluidcommunication with the central opening 422. A perimeter of the opening424 in the trailing end includes the recesses 404 and ridges 402configured to mate with the distal end 122 of the tube 120 or attachmentmember. In other embodiments, the opening 424 can include otherengagement features configured to mate with corresponding engagementfeatures on the distal end of the tube 120 or attachment member. Theopening 424 is sized to mate with or receive the tube 120 or attachmentmember and can be larger than openings included in various other cagesto mate with insertion instruments. When the distal end 122 of the tube120 is coupled to the cage 400, the bone graft material can be deliveredthrough the opening 424 into the central opening 422 to promote bonegrowth into and through the central opening 424 and promote fusion.

As shown, the sidewalls 414, 416 can include holes 426 that are in fluidcommunication with the central opening 422. The holes 426 allow bonegraft material delivered into the central opening 422 from the tube 120to spread to the surrounding disc space outside of the cage 400, forexample as shown in FIG. 11E. In the illustrated embodiment, each of thesidewalls 414, 416 includes three holes 426, although more or fewerholes are also possible. In the illustrated embodiment, the holes 426have an at least partially conical shape. As shown, a portion of theholes 426 adjacent the central opening 422 and inner surfaces of thesidewalls 414, 416 is generally circular. The perimeter of the holes 426then flares or tapers outwardly toward outer surfaces of the sidewalls414, 416, as shown in FIG. 11C. In other embodiments, the perimeter ofthe holes 426 can be flared or tapered continuously from the innersurfaces of the sidewalls 414, 416 to the outer surfaces of thesidewalls 414, 416. The holes 426 allow bone graft material to spreadfrom inside the central opening 422 to outside of the cage 400 in thesurrounding disc space. The tapered shape of the holes 426 allows orpromotes dispersal of bone graft material outside of the cage 400 inmultiple directions and over a greater area and can allow for a moreuniform distribution of bone graft material around the cage 400 in thesurrounding disc space to promote fusion.

FIG. 12 illustrates an example embodiment of an expandable cage 450configured to be coupled to the tube 120 as shown. In some cases inwhich an expandable cage is used, the surgeon may fill or pack the cagewith bone graft before inserting the cage in the patient, then expandthe cage within the disc space. However, this then results in excessspace within the cage not filled with bone graft material. Coupling thebone graft delivery device 100 to the cage 450 or another expandablecage with the cage in the disc space allows the cage to be filled as itis expanded within the disc space or after it has been expanded tomaximize filling of the cage with the bone graft material.

In the illustrated embodiment, the cage 450 has a proximal wall 462, adistal wall 460, and first and second sidewalls 464, 466. The sidewalls464, 466 have an upper bone contacting surface 468 configured to contacta superior vertebra and a lower bone contacting surface 470 configuredto contact an inferior vertebra. The cage 450 also has a central opening472 and a hole 474 in the proximal wall 462 in fluid communication withthe central opening 472 and configured to receive the distal end of thetube 120. The distal end of the tube 120 can be coupled to the proximalwall 462 via a threaded connection as soon or any other suitablemechanism. Similar to the embodiment of FIGS. 11A-11D, one or both ofthe first and second sidewalls 464, 466 can include one or more holes476 in fluid communication with the central opening 472. In theembodiment of FIG. 12, the holes 476 are connected to one another. Inthe illustrated embodiment, a distance between the upper bone contactingsurface 468 and the lower bone contacting surface 470 is greateradjacent the distal wall 460 than the proximal wall 462, and a height ofthe cage 450 increases from the proximal wall 462 to the distal wall460. In some embodiments, the distal wall 460 includes a mechanism thatexpands the distal end of the cage 450 relative to the proximal end. Thedistal end of the tube 120 can be coupled to the cage 450 before orafter the cage 450 is expanded to allow the cage 450 to be filled withbone graft material as it is being expanded or after it has beenexpanded.

In some embodiments, the bone graft delivery device 100 can include anendoscope or endoscopic camera to allow for visualization duringinsertion of the tip 130 to the target area, decortication, and/ordelivery of the graft material. This can advantageously allow thephysician to visualize muscles, nerves, and other tissue and structuresunder the skin to help avoid and inhibit damage to sensitive structures.As shown in FIG. 8A, an endoscope 140 can extend along the tube 120 andcan be removably or permanently coupled to the tube 120. In someembodiments, the endoscope 140 or camera can extend through the lumen ofthe tube 120, for example as shown in FIG. 8B.

The bone graft delivery device 100 can also or alternatively be used inconjunction with various image-guided surgery systems and devices, suchas, for example, StealthStation® Navigation Systems available fromMedtronic or other navigation systems. In some embodiments, for exampleas shown in the example embodiment of FIGS. 9A and 9B, the bone graftdelivery device includes a guide 170 having markers 172 configured to bevisualized with, for example, fluoroscopy or x-ray. The guide 170 caninclude a sheath 174 configured to receive the tube 120 to couple theguide 170 to the bone graft delivery device. A surgical navigationsystem can include an imaging modality, such as an X-ray or CT scanneror fluoroscope, and a camera. In use, during preparation for animage-guided surgical procedure, a reference frame, which can includeradiopaque markers, is attached to a pin positioned in a referencelocation in the patient's spine or other target area. Images are taken,and the image data is transferred to the navigation system forprocessing and registration. During the procedure, the camera can trackthe position of the markers 172 on the guide 170 relative to the markerson the reference frame. The navigation system can process imagesobtained by the camera and/or an imaging modality to display theposition of the bone graft delivery device on the pre-operative images.In some embodiments, the navigation system can process images obtainedby an endoscopic camera extending alongside or through the tube 120 asdescribed herein.

In some embodiments, one or more handles 102 of a bone graft deliverydevice can be provided in a system or kit with one or more tips 130,tubes 120, and/or other instruments. The kit can allow a surgeon orother medical personnel to select an appropriate tube 120 and/or tip 130for the particular patient, procedure, and/or treatment location. Asdescribed above, certain tip 130 configurations can be suited forcertain target locations. For some procedures, the surgeon may select acurved or straight tube 120 to help improve access to the particulartarget location and/or may select from two or more tubes 120 havingdifferent lengths. In some embodiments, the kit can include anendoscopic camera. In some embodiments, the kit can include one or moreseparate rasping instruments. The kit can include various otherinstruments that might be used during an orthopedic procedure.

For example, FIG. 13 illustrates an example embodiment of a kit that canbe provided to a surgeon in a tray. In the illustrated embodiment, thekit includes a handle 102, a relatively shorter tube 120 a andcorresponding relatively shorter plunger 112 a, a relatively longer tube120 b and corresponding relatively longer plunger 112 b, and a pusherrod 312. The kit can include more or fewer tubes 120 and/or plungers112. As shown, each tube 120 a, 120 b includes a tube end cap 124 on itsdistal end. Each tube also includes a proximal end cap 124 b on itsproximal end for shipping and storage. For use, the surgeon or othermedical professional selects the desired tube 120 a, 120 b, removes theproximal end cap 124 b, and couples the proximal end of the selectedtube 120 a, 120 b to the base 62 of the handle 102. In the case of ahandle 102 having a funnel 104, the surgeon or other medicalprofessional can then proceed to load bone graft into the handle 102,use the pusher rod 312 to urge the bone graft material into the tube 120a, 120 b, then remove the pusher rod 312 and select the appropriateplunger 112 a, 112 b for use in delivering the bone graft material usingthe bone graft delivery device 100. In some embodiments, one or more ofthe tubes 120 a, 120 b and/or handle 102 can be provided pre-loaded withbone graft material.

In some embodiments, a kit includes a handle 102, one or more prefilledtubes 120, and one or more plungers 112. For example, the kit caninclude one or more tubes 120 prefilled with a synthetic bone graftmaterial. In some embodiments, the synthetic bone graft materialprefilled in the tube(s) 120 has a composition of about 40-95% calciumphosphate and about 5-60% collagen. As another example, the kit caninclude one or more tubes 120 prefilled with a demineralized bone matrixmaterial. Any prefilled tubes can be sealed in the kit or other packagefor shipment and storage to preserve the integrity of the bone graftmaterial. In some embodiments, a kit can be provided including a handle102, one or more tubes 120, one or more plungers 112, and a bone graftloading device 600, 700. The loading device 600, 700 can be used to loadthe tube(s) 120 with any appropriate bone graft material the surgeondesires or requires. In some embodiments, the kit can further includeone or more types of bone graft material.

In one embodiment, the device 100 described herein may be used inminimally invasive spinal surgery. For example, in a conventionalposterolateral spine procedure, screws and or fusion cages may bedelivered to adjacent vertebrae using small incisions made in apatient's back. It may additionally be desirable to deliver bone graftmaterial to the surgical location, e.g., to the transverse processes,disc spaces, lamina, or facet joints, through one of these smallincisions. The device described herein is sized to be delivered througha minimally invasive opening made in the patient's skin (e.g., through askin incision of 4 cm or less), and configured so that the tip can bepositioned adjacent a pedicle screw or other desired location. Theoptional curvature of the tube 120 can facilitate positioning of the tip130 at desired spinal locations and allows, for example, insertion ofthe device 100 through an incision over one vertebra, and positioning ofthe tip 130 at an adjacent vertebra. Alternatively, the device can bedelivered through any desired opening made in the patient's skin (e.g.,minimally invasive, mini-open, or open). If needed, the optional jaggededges or other surface 134 on the device can be used to decorticatedesired bone locations, causing bleeding of the bone and creating asurface that promotes bone fusion. The trigger 110 or other actuationmechanism can then be actuated to deliver bone graft material throughthe tube 120 lumen and optional openings 132 in the tip 130 to promotefusion of the bone.

In some embodiments, an endoscope or camera can be inserted through thetube 120 and used to help guide the physician or other medicalprofessional to the target location and/or to allow the physician toevaluate the area. If the physician wants to decorticate the bone, thephysician can remove the endoscope or camera, insert the shaft 150having the burr 152 or another suitable rasping instrument, anddecorticate the target area. In some embodiments, the tube 120 can beinserted into the patient with the shaft 150 or other rasping instrumentalready inserted or with a rasping tip 130 attached and the physiciancan use an endoscope, camera, navigation system, or the like placedalongside, adjacent, or proximal the tube 120 to navigate to and/orevaluate the target area. Once the target location is ready, thephysician can remove the shaft 150 or other rasping instrument ifpresent and deliver the bone graft material, for example, using thetrigger 110.

Although use of the device 100 has been described with respect to anexample spinal procedure, the device 100 can also be used in otherspinal procedures and other orthopedic applications to deliver bonegraft material to other locations in the body (for example, the femur ortibia).

Various modifications to the implementations described in thisdisclosure may be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the principles and features disclosed herein. Variouscombinations and subcombinations of the various features describedherein are possible. For example, a bone graft delivery device caninclude a handle and tube and may or may not include a distal raspingtip. The tube can be integrally formed with the handle and/or a distalrasping tip and/or any or all of the components can have a modularconfiguration such that various tubes and/or distal tips can be selectedand exchanged as desired by the surgeon or other user. A bone graftdelivery device can have a curved or straight tube. A distal tip canhave any suitable configuration, including bullet-shaped, flat, conical,or any other configuration. A bone graft delivery device can beconfigured to received and/or supplied with various endoscopes, othercameras or imaging equipment, and/or guide brackets for imagingequipment. A bone graft delivery device can include any suitableratcheting mechanism to advance bone graft material through the devicefor delivery and may include a plunger and/or pusher rod. Certainembodiments of the invention are encompassed in the claim set listedbelow.

What is claimed is:
 1. A bone graft delivery system kit comprising: abone graft loading assembly comprising: a first tubular body configuredto be loaded with a bone graft material; a second tubular bodyconfigured to receive bone graft material from the first tubular body;and a first plunger comprising: a plunger shaft configured to beadvanced within the first tubular body along a first axis; and a plungerbody coupled to an end of the plunger shaft and configured to seal withan inner wall of the first tubular body so as to urge bone graftmaterial to flow from the first tubular body into the second tubularbody when the plunger shaft is advanced within the first tubular body,the second tubular body being configured to facilitate flow of bonegraft material within the second tubular body along a second axisorthogonal to the first axis; wherein the first tubular body comprises:a proximal end configured to receive the plunger body and plunger shaft;a distal end; and an opening positioned between the proximal end and thedistal end configured to establish fluid communication between the firsttubular body and the second tubular body; an elongate tube configured tobe coupled to the second tubular body of the bone graft loading assemblyto be filled with bone graft material; a handle configured to be coupledto the elongate tube; and a second plunger configured to be advancedwithin the elongate tube.
 2. The kit of claim 1, wherein the secondtubular body is integrally formed with the first tubular body.
 3. Thekit of claim 1, wherein the bone graft loading assembly comprises a tubestop filling an internal volume of the first tubular body between thedistal end of the first tubular body and the opening.
 4. The kit ofclaim 3, wherein the tube stop extends proximally to a distal end of theopening.
 5. The kit of claim 1, further comprising a tip configured tobe coupled to an end of the elongate tube, the tip comprising one ormore openings configured to deliver bone graft material and a surfaceconfigured to decorticate bone.
 6. The kit of claim 1, furthercomprising a pusher rod configured to be removably received in theelongate tube.
 7. The kit of claim of claim 1, wherein the secondplunger comprises a rubber tip.
 8. A bone graft delivery system kitcomprising: a bone graft loading assembly comprising: a first tubularbody configured to be loaded with a bone graft material; a secondtubular body coupled to the first tubular body; and a first plungercomprising: a plunger shaft configured to be advanced in the firsttubular body along an axis; and a plunger body coupled to an end of theplunger shaft and configured to seal with an inner wall of the firsttubular body so as to urge bone graft material to flow out of the firsttubular body when the plunger shaft is advanced within the first tubularbody; wherein the first tubular body comprises: a proximal endconfigured to receive the plunger body and plunger shaft; a distal end;and an opening positioned between the proximal end and the distal endconfigured to establish fluid communication between the first tubularbody and the second tubular body; an elongate tube configured to becoupled to the bone graft loading assembly to be filled with bone graftmaterial, the elongate tube having a longitudinal axis orthogonal to theaxis along which the plunger shaft advances in the first tubular bodywhen the elongate tube is coupled to the bone graft loading assembly,wherein the elongate tube is configured to couple to the second tubularbody; a handle configured to be coupled to the elongate tube; and asecond plunger configured to be advanced within the elongate tube. 9.The kit of claim of claim 8, wherein the second plunger comprises arubber tip.
 10. The kit of claim 1, further comprising the bone graftmaterial.
 11. The kit of claim 8, further comprising a pusher rodconfigured to be removably received in the elongate tube.
 12. The kit ofclaim 8, wherein the second tubular body is positioned to facilitate theflow of bone graft through the second tubular body parallel to thelongitudinal axis of the elongate tube when the elongate tube is coupledto the second tubular body.
 13. The kit of claim 8, wherein the secondtubular body is integrally formed with the first tubular body.
 14. Thekit of claim 8, wherein the bone graft loading assembly comprises a tubestop filling an internal volume of the first tubular body between thedistal end of the first tubular body and the opening.
 15. The kit ofclaim 14, wherein the tube stop extends proximally to a distal end ofthe opening.
 16. The kit of claim 8, further comprising the bone graftmaterial.
 17. A bone graft delivery system kit comprising: a bone graftloading assembly comprising: a tubular body configured to be loaded witha bone graft material; and a first plunger comprising: a plunger shaftconfigured to be advanced in the tubular body along an axis; and aplunger body coupled to an end of the plunger shaft and configured toseal with an inner wall of the tubular body so as to urge bone graftmaterial to flow out of the tubular body when the plunger shaft isadvanced within the tubular body; an elongate tube configured to becoupled to the bone graft loading assembly to be filled with bone graftmaterial, the elongate tube having a longitudinal axis orthogonal to theaxis along which the plunger shaft advances in the tubular body when theelongate tube is coupled to the bone graft loading assembly; a handleconfigured to be coupled to the elongate tube; a second plungerconfigured to be advanced within the elongate tube; and a tip configuredto be coupled to an end of the elongate tube, wherein the tip comprisesone or more openings configured to deliver bone graft material and asurface configured to decorticate bone.
 18. The kit of claim 17, whereinthe tubular body comprises a first tubular body, the bone graft loadingassembly further comprising a second tubular body coupled to the firsttubular body, wherein the elongate tube is configured to couple to thesecond tubular body.
 19. The kit of claim 18, wherein the second tubularbody is positioned to facilitate the flow of bone graft through thesecond tubular body parallel to the longitudinal axis of the elongatetube when the elongate tube is coupled to the second tubular body. 20.The kit of claim 18, wherein the second tubular body is integrallyformed with the first tubular body.
 21. The kit of claim 18, whereinfirst tubular body comprises: a proximal end configured to receive theplunger body and plunger shaft; a distal end; and an opening positionedbetween the proximal end and the distal end configured to establishfluid communication between first tubular body and the second tubularbody.
 22. The kit of claim 17, further comprising a pusher rodconfigured to be removably received in the elongate tube.
 23. The kit ofclaim 17, wherein the second plunger comprises a rubber tip.
 24. The kitof claim 17, further comprising the bone graft material.